Kornimate/medical-research-clean huggingface dataset:
strength after elbow fractures in the elderly

Conditions: Fracture;Elbow

Summary: elderly patients strength and function, specifically the ability to rise from a seat after either operative or non operative treatment of an mayo type 2 olecranon fracture.

elderly patients with an olecranon fracture will receive appropriate treatment as determined by the treating surgeon. patients will then be assessed at 6 weeks, 6 months and 12 months post treatment. assessments include, range of motion, patient reported outcomes and a strength test.

Eligibility criteria:
inclusion criteria: 1. ≥65 years of age 2. mayo type ii olecranon fracture 3. ambulatory (with or without the use of walking aides) exclusion criteria: 1. additional injuries to the affected arm or contralateral arm 2. associated nerve injury 3. dementia or cognitive impairment that inhibits the collection of outcome measures 4. likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.) 5. injury or previous deficit to the contralateral arm 6. currently enrolled in any other research study involving drugs or medical devices 7. open fractures 8. inability to provide informed consent

Keywords: operative non operative
help-seeking for health problems in people with parkinson's

Conditions: Parkinson Disease

Summary: non-motor symptoms (nms) are common in parkinson's disease (pd) and cause significant distress and decreased quality of life. a high rate of non-declaration of nms by patients means that many nms remain unrecognized and untreated, even in specialist clinical services. in phase one of this research qualitative interviews (phase 1) were guided by the theoretical domains framework and used to identify the barriers for help-seeking. a quantitative questionnaire survey (phase 2) examined the significance of these barriers to help seeking. the present study aims to develop (phase 3) and test the feasibility (phase 4) of a targeted behavioural intervention of barriers which were identified in phases 1 and 2 which prevent help-seeking for nms in patients with pd. as with phases 1 and 2, the feasibility trial will include people with unreported burdensome nms, who have not reported them to their pd consultant or nurse. the intervention has been co-designed by people affected by parkinson's and targets the barriers identified in the previous phases of the research. in phase three of the research, 'think-aloud' interviews will be used to further develop the intervention so that it is acceptable and easy to use. in the final phase, a feasibility trial will be conducted to examine efficacy of the intervention for increasing help-seeking for undeclared nms. the study has implications for using a theoretically driven behavioural intervention to promote help-seeking for nms and ultimately increase receipt of clinical care for nms among patients with pd.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's * access to a computer and internet connection * experiencing at least one unreported non-motor symptom exclusion criteria: * presence of sensory loss or communication difficulty (including inadequate command of english) sufficient to interfere with the assessments. * severe cognitive impairment that would make participation in the intervention problematic or distressing. this will be assessed using the telephone interview for cognitive status-modified (tics-m, brandt et al., 1993). people with a score of less than 20 will be excluded.
cisplatin and s-1 with or without nimotuzumab in untreated advanced gastric adenocarcinoma

Conditions: Stomach Neoplasms

Summary: in this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to cs chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. sixty-two patients are required and randomly assigned (1:1) to each group. the control regimen (cs chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.


Eligibility criteria:
inclusion criteria: 1. provision of written informed consent; 2. male or female; and aged ≥ 18 years; 3. histologically verified, untreated, metastatic or locally advanced inoperable adenocarcinoma or signet ring cell carcinoma of the stomach or gastroesophageal junction; 4. at least one radiographically documented measurable lesion according to response evaluation criteria in solid tumors version 1.1(recist1.1) criteria; 5. an eastern cooperative oncology group (ecog) performance status of 0-2; and a life expectancy ≥ 3months; 6. no previous palliative chemotherapy; 7. adequate function of vital organs: white blood cells (wbc) ≥ 4.0×109/l, neutrophils (ana) ≥ 1.5 × 109/l, platelets ≥ 100 × 109/l, hemoglobin ≥ 90g/l (blood transfusion is permitted if necessary), serum bilirubin ≤ 1 times the upper normal limit (unl), aspartate aminotransferase (ast) and alanine aminotransferase (alt) \< 2.5 times the unl, alkaline phosphatase (akp) ≤ 5 times the unl, creatinine (cr) ≤ 1 times the unl, normal electrocardiography (ecg). exclusion criteria: 1. pregnant or lactating patients, or reproductive women without effective contraception; 2. patients with only non-measurable disease: small lesions (longest diameter \< 10mm or pathological lymph nodes with ≥ 10 to \< 15mm short axis), bone lesions, leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung; abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques. 3. symptomatic of brain metastasis; 4. patients with clinically severe comorbidity including diabetes mellitus, hypertension, heart disease, or chronic active hepatitis (hbv carrier can be enrolled if circumstance permits ); 5. no previous radiotherapy for measurable lesions.

Keywords: nimotuzumab gastric adenocarcinoma cisplatin s-1 epidermal growth factor receptor
group curriculum for improving survivorship outcomes in adolescent and young adult cancer survivors

Conditions: Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Summary: this clinical trial studies the effectiveness of a group curriculum in improving survivorship outcomes in adolescent and young adult (aya) cancer survivors. many aya survivors typically do not feel prepared to re-enter "daily life" and would likely benefit from structured interventions to offer education and support in a timely manner as to prepare them for the challenges of life in survivorship. a 6-week group curriculum, designed to specifically meet the needs of aya cancer survivors and facilitated by licensed social workers, may meet the unique needs of young adults who have survived a cancer diagnosis, and if so, the curriculum could be licensed and used across mayo clinic sites and potentially at other cancer centers nationwide.

primary objectives: i. social workers will develop a curriculum to facilitate psychoeducational, skill-based, and process-oriented group for patients who have entered survivorship. ii. to determine if a specific 6 weeklong psychoeducational, skill-based, and process-oriented peer group curriculum results in improved quality of life for adolescents and young adult cancer survivors. iii. to demonstrate the feasibility of this curriculum to address the needs of this population. outline: participants attend an online group facilitated by two oncology social workers and receive information regarding coping with cancer survivorship as a young adult, as well as discuss survivorship issues/concerns with peers.

Eligibility criteria:
inclusion criteria: * age 18-39 * is a patient of mayo clinic arizona for oncologic care and/or follow-up * history of cancer diagnosis * treated with curative intent * completed cancer treatment within 6 months to 2 years prior to group attendance * ability to read/write/speak english * ability to participate in a group setting * ability to commit to attending all six group meetings exclusion criteria: * inability to read/write/speak english * no internet or computer access * not receiving care at mayo clinic arizona * currently receiving treatment for cancer * is unable to sit comfortably for 90 minutes * was not treated with curative intent * is on hospice care * co-morbid systemic illness or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessments
factors associated with the use of a high volume cancer center by black women with ovarian cancer: a qualitative study

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Summary: the purpose of this study is to explore the experiences of black women who receive care for ovarian cancer at memorial sloan kettering cancer center, or "msk" for short. the study consists of interviews with black women who recently obtained some part of their ovarian cancer care at msk.


Eligibility criteria:
inclusion criteria: * participant must have been diagnosed with ovarian, fallopian tube or primary peritoneal cancer and treated by an msk physician. * participants must be able to provide verbal informed consent. * participants must be 18 years of age or older. * participants must self-identify as black/african american. * participant must be able to understand and speak in english exclusion criteria: * inability or refusal to identify race/ethnicity. * presence or development of a physical, cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent or to understand the study or complete the interview.

Keywords: interviews 16-1378
a phase i/ii, open label, escalating dose, pilot study to assess effect, safety, tolerability and pk of multiple sc doses of drisapersen in patients with duchenne muscular dystrophy and to assess the potential for iv dosing as an alternative route of administration

Conditions: Muscular Dystrophies

Summary: the purpose of the extension phase of this study is to determine whether drisapersen is effective in the treatment of boys with duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping.


Eligibility criteria:
inclusion criteria: * boys aged between 5 and 16 years inclusive. * duchenne muscular dystrophy resulting from a mutation correctable by treatment with pro051. * not ventilator dependent. * life expectancy of at least six months. * no previous treatment with investigational medicinal treatment within six months prior to the study. * willing and able to adhere to the study visit schedule and other protocol requirements. exclusion criteria: * aberrant rna splicing and/or aberrant response to pro051, detected by in vitro pro051 assay during screening. * known presence of dystrophin in 5% of fibers in a pre-study diagnostic muscle biopsy. * severe muscle abnormalities defined as increased signal intensity in \>50% of the tibialis anterior muscle at mri. * fev1 and/or fvc \<60% of predicted. * current or history of liver or renal disease. * acute illness within 4 weeks prior to treatment (day 1) which may interfere with the measurements. * severe mental retardation which in the opinion of the investigator prohibits participation in this study. * severe cardiac myopathy which in the opinion of the investigator prohibits participation in this study. * need for mechanical ventilation. * creatinine concentration above 1.5 times the upper limit of normal (age corrected). * serum asat and/or alat concentration(s) which suggest hepatic impairment. * use of anticoagulants, antithrombotics or antiplatelet agents. * subject has donated blood less than 90 days before the start of the study. * current or history of drug and/or alcohol abuse. * participation in another trial with an investigational product.

Keywords: drisapersen
relationship between hypoxia and endocrine response in human breast cancer

Conditions: Breast Cancer; Hypoxia

Summary: the aim of our current study was to analyze whether 18f-labeled fluoromisonidazole (1-(2-nitro-1-imidazolyl)- 2-hydroxy-3-fluoropropane \[18f-fmiso\]) pet/ct and expression of hif-1-alpha could predict response of primary endocrine therapy in er-positive breast cancer

approximately 30% of er-positive breast cancer will unfortunately display primary resistance to hormonal therapy, and some may develop acquired resistance to the therapy after initial treatment. hypoxia is a normal phenomenon in solid tumors that arises, in part, from uncontrolled proliferation and immature blood vessels. previous studies have demonstrated hypoxia significantly reduced both the growth-promoting effects of estradiol (e2) and the growth-inhibitory effects of an antiestrogen on er-positive breast cancer cell lines. a recent study comparing neoadjuvant letrozole with letrozole plus metronomic cyclophosphamide found that increased levels of hif-1a were significantly associated with resistance to treatment. taken together, these data indicate that hypoxia might be associated with endocrine resistance in breast cancer. with pet/ct, radiolabeled hypoxia-avid compounds can be applied to evaluate oxygenation status in experimental or human tumors. 18f-labeled fluoromisonidazole (1-\[2-nitro- 1-imidazolyl\]-2-hydroxy-3-fluoropropane \[18f-fmiso\]) pet/ct is the most widely used one in the clinic. studies have demonstrated an excellent correlation between the 18f-fmiso uptake and oxygenation status of several cancers including breast cancer. the major aim of our study was to analyze uptake of 18ffmiso as well as the ihc expression of hif-1-alpha in er-positive breast cancers, and to predict the clinical, pathological and biological response of primary endocrine therapy.

Eligibility criteria:
inclusion criteria: 1. postmenopausal female 2. with primary invasive er positive breast cancer pathologically approved by core needle biopsy 3. the target lesion must be measurable and maximum diameter should be over 2cm. 4. require and accept endocrine therapy 5. never treated with endocrine therapy before 6. patients must have an ecog performance status of 0 to 2 7. leucocyte count must be ≥ 3.0\*10\^9/l and platelet count must be ≥ 40\*10\^9/l; ast/sgot or alt/agpt must be \< 2 times the uln; serum creatinine must be \< 2 times the uln exclusion criteria: 1. patients with brain and liver metastasis 2. previous history of severe heart dysfunction (above class iii), infection, osteoporosis, bone related event or disease in endocrine system 3. combination of other anticancer therapy, with the exception of biphosphonate

Keywords: breast cancer hypoxia hypoxia related gene endocrine therapy treatment resistance
healthyweighthub.fi: web-based management of obesity in a real-life clinical setting

Conditions: Obesity

Summary: this study evaluates the effectiveness of a web-based obesity management program healthyweightcoaching (hwc), within a healthyweighthub.fi (hwh) platform. hwc is a 12-month intervention within a real-life clinical setting. the program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy. in addition to the automated, interactive program, hwc includes a personal coach allocated to each patient. the patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in finland.

obesity is one of the major public health problems globally and it increases the risk of many obesity-associated diseases. treatment of obesity requires long-term interventions, but nevertheless, it is challenging to provide long-term treatment when resources in real-life health care systems are limited. new cost-effective and accessible intervention methods are needed. the modern treatment of obesity is based on behavioral changes that modify one´s daily lifestyle, which, according to recent research, are effective especially in the prevention of diabetes. however, little is known about the utilization and effectiveness of online programs using novel interactive technologies. the aim of this study is to evaluate the effectiveness of a real-life web-based obesity management program (healthyweightcoaching, hwc) on weight loss, health, quality of life, and factors predicting long term success in treating overweight adult patients. healthy weight coaching is a novel 12-month intervention within a real-life clinical setting. the program includes a combination of nutrition, physical activity, and cognitive behavioral approaches, with a strong basis in acceptance and commitment therapy. the program is structured around weekly exercise modules. in addition to the automated, interactive program, hwc includes a personal coach allocated to each patient. the patients are enrolled through referrals from primary care, occupational health, other hospitals, or from private health care units nationwide in finland. the program is free for the patient to use. the 12-month intervention is followed by a 5-year monitoring period. questionnaires on health, quality of life, and lifestyle are collected at 0, 3, 6, 9, and 12-month time points. body weight is collected by weekly logs. the recruitment is ongoing as the program is currently used in clinical practice.

Eligibility criteria:
inclusion criteria: * age over 18 years * body mass index (bmi) ≥ 25 kg/ m² * the possibility to use a computer and /or a smartphone with access to the internet * willingness to participate in the digital treatment program exclusion criteria: * diagnosed severe illness requiring assessment from the specialty care obesity center * pregnancy or breastfeeding

Keywords: ehealth, web-based, internet-based, digital, body weight
the cortisol levels during cardiac surgery. the comparison between etomidate and thiopentone

Conditions: Coronary Artery Disease; Valvular Heart Disease

Summary: during induction for cardiac surgery, patient hemodynamic stability is achieved by using anesthetic drugs which least affects hemodynamics such as benzodiazepines, etomidate. etomidate although has been used for a long time but its safety regarding cortisol synthesis suppression is still doubtful. this study measures the changes in cortisol levels during cardiac surgery with the use of cardiopulmonary bypass by comparison between two inductive agents (etomidate and thiopentone). recording data also include hemodynamic changes during induction, inotropic use for coming of cardiopulmonary bypass, blood glucose levels, amount of insulin usage, length of icu and hospital saty.

ninety-two cardiac patients who undergoing cardiopulmonary bypass graft (cabg) or valve surgery will be enrolled in this study. they will be randomized into two groups (thiopentone and etomidate groups). apart from different in two inductive drugs, other anesthetics will be the same. we record hemodynamic changes during inductions, inotropic use (dose and duration), blood glucose levels, total insulin requirement to keep blood glucose 140-180 mg% in perioperative period, duration of mechanical ventilation, length of stay in icu and total hospital length of stay. the changes in cortisol levels will be recorded at time 0 (before induction), 2, 4, 8, 24 hours in 26 patients (13 patients in each group and only patients who are the first in the operating list (morning list)).the 26 patients is needed from sample size equation for the changes in cortisol level and the 92 patients is calculated from the differences in inotropic use.

Eligibility criteria:
inclusion criteria: 60 year or older cardiac patient undergoing cardiac surgery (cabg or valve surgery) with the use of cardiopulmonary bypass - exclusion criteria: * redo or emergency operation * complex and prolong operation * history of adrenal insufficiency or steroid use * already has inotropic drugs to support hemodynamics * creatinine \> 2.0 mg/dl

Keywords: etomidate cortisol level inotrope cardiac patients
poplar-type propolis dry extract esit12 : immunomodulation efficacy study

Conditions: Upper Respiratory Tract Infection (URTI)

Summary: the aim of the present investigation is to evaluate the immunomodulation effect of esit12, a poplar-type propolis dry extract standardized in polyphenols, and its efficacy in subjects at risk of contracting upper respiratory tract infections (urtis), during a 12-week supplementation period plus 4-week follow-up. the number of onset of upper respiratory tract infections, the symptoms severity and lasting and interferences with well-being will be assessed with wurss-24 questionnaire. the quality of life will be assessed with the sf-36 questionnaire and a testimonial. blood immune markers will also be assessed. finally, long lasting benefits will additionally be evaluated 4 weeks after end of the supplementation period. the design of the study is double-blind, randomized, parallel and placebo controlled.


Eligibility criteria:
inclusion criteria: * inactive or minimally active according to the ipaq short form questionnaire * bmi 18,5-29,9 exclusion criteria: * pregnant women, breastfeeding women, women positive at beta-hcg serology test and who hope to become pregnant * allergy to beehive products and known allergy (general) * cystic fibrosis * congenital or acquired immunodeficiency syndrome and disease * history of asthma (within prior 24 months) or chronic respiratory disease * subjects who underwent medical treatment for covid-19 within last 3 months * history of immune system disorder or auto-immune disorder * history of treated diabetes or treated hypertension * evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, and malignancies * cancers * those considered unsuitable for the participation by the physician * no vaccination within 12 weeks prior to enrolling in the study * no antibiotics within 12 weeks prior to enrolling in the study * no anti-inflammatory drugs within 4 weeks prior to enrolling in the study * no steroids within 12 weeks prior to enrolling in the study * no immunological drugs within 4 weeks prior to enrolling in the study * no food/dietary supplements within 4 weeks prior to enrolling in the study * no current or recent participation in another clinical trial (within 30 days prior to screening)